Slide 1: Anaphylm Sublingual Film Oral Allergy Syndrome Challenge Study Supplemental Materials
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. Anaphylm (epinephrine) Sublingual Film Oral Allergy Syndrome Challenge Study Supplemental Materials October 24, 2024 1
Slide 2: Disclaimer
Advancing medicines. Solving problems. Improving lives. 2 ® Disclaimer Certain statements in this presentation include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend
Slide 3: Key messages: Oral Allergy Syndrome (OAS) challenge study
Advancing medicines. Solving problems. Improving lives. 3 Key messages: Oral Allergy Syndrome (OAS) challenge study 1. Subjects experienced rapid symptom relief ▪ 94% of subjects were categorized as having moderate or severe reactions after exposure to an allergen ▪ Administration of Anaphylm (epine
Slide 4: OAS challenge study design
Advancing medicines. Solving problems. Improving lives. 4 OAS challenge study design Subjects with OAS (n=36) Adrenalin (IM) (no allergen) Anaphylm¹ (after allergen) Anaphylm (no allergen) Adrenalin (IM) (no allergen) Anaphylm¹ (after allergen) Anaphylm (no allergen) single dose (n=18) repeat dose (
Slide 5: OAS challenge study induced subject reactions
Advancing medicines. Solving problems. Improving lives. 5 OAS challenge study induced subject reactions Screening Clinician tracks patient symptoms until resolution First subject visit Second subject visit Dosing 1. Subjects received either single dose or repeat dose of Anaphylm 2. Clinician tracks
Slide 6: Subjects were exposed to an allergen prior to dosing
Advancing medicines. Solving problems. Improving lives. Subjects were exposed to an allergen prior to dosing 6 Adrenalin (IM) no allergen exposure Allergen # Exposures Pineapple 14 Red Apple 7 Kiwi 7 Cherry 3 Banana 2 Avocado 2 Fig 2 Grapefruit 2 Lychee 2 Tangerine 2 All other 4 Total 47¹ Select Sym
Slide 7: Complete symptom resolution occurs rapidly after Anaphylm administration
Advancing medicines. Solving problems. Improving lives. Complete symptom resolution occurs rapidly after Anaphylm administration¹ ▪ Median time to complete symptom resolution was 12 minutes after Anaphylm administration ▪ Median time to resolution was 74 minutes without Anaphylm administrations 7 0%
Slide 8: Symptom relief correlates to Anaphylm PK levels
Advancing medicines. Solving problems. Improving lives. Symptom relief correlates to Anaphylm PK levels¹,² 8 1. Aquestive Therapeutics data on file. 2. Data represent per protocol patient population. Time comparison of geometric mean baseline corrected epinephrine concentration and symptom resolutio
Slide 9: Symptom relief was also observed with repeat dosing of Anaphylm
Advancing medicines. Solving problems. Improving lives. Symptom relief was also observed with repeat dosing of Anaphylm¹,² 9 1. Aquestive Therapeutics data on file. 2. Data represent per protocol patient population. Time comparison of geometric mean baseline corrected epinephrine concentration and s
Slide 10: Anaphylm PK profile remains consistent with and without allergen exposure
Advancing medicines. Solving problems. Improving lives. Anaphylm PK profile remains consistent with and without allergen exposure¹,² 1. Aquestive Therapeutics data on file. 2. Data represent per protocol patient population. Geometric mean baseline-adjusted epinephrine concentration over time in OAS
Slide 11: Anaphylm single dose meets primary endpoints under oral allergen challenge
Advancing medicines. Solving problems. Improving lives. 11 Anaphylm single dose meets primary endpoints under oral allergen challenge¹,² Administration AUC0- 10min AUC0- 20min AUC0- 30min AUC0- 45min Manual IM (n=24) 6.0 18.9 39.0 76.0 Anaphylm with allergen (n=23) 14.4 63.2 97.0 132.1 Anaphylm with
Slide 12: Anaphylm repeat dose meets primary endpoints under oral allergen challenge
Advancing medicines. Solving problems. Improving lives. 12 Anaphylm repeat dose meets primary endpoints under oral allergen challenge¹,² Administration AUC0- 10min AUC0- 20min AUC0- 30min AUC0- 45min Manual IM (n=22) 5.1 15.5 39.2 99.4 Anaphylm with allergen (n=23) 10.1 62.6 216.8 360.5 Anaphylm wit
Slide 13: Single dose pharmacodynamics
Advancing medicines. Solving problems. Improving lives. 13 Single dose pharmacodynamics¹,² Anaphylm elicits the desired pharmacodynamic response in key metrics of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Pulse (HR), consistent with and without allergen exposure 1. Aquestive
Slide 14: Repeat dose pharmacodynamics
Advancing medicines. Solving problems. Improving lives. 14 Repeat dose pharmacodynamics¹,² Anaphylm elicits the desired pharmacodynamic response in key metrics of SBP, DBP and HR, consistent with and without allergen exposure 1. Aquestive Therapeutics data on file. 2. Data represent per protocol pat
Slide 15: OAS challenge study single dose safety summary
Advancing medicines. Solving problems. Improving lives. 15 OAS challenge study single dose safety summary¹ ▪ All treatment-emergent adverse events (TEAEs) were categorized as mild (Grade 1) ▪ No serious adverse events (SAEs) were observed ▪ TEAEs were transient and resolved without medical intervent
Slide 16: OAS challenge study repeat dose safety summary
Advancing medicines. Solving problems. Improving lives. 16 OAS challenge study repeat dose safety summary¹ ▪ Most TEAE (96.2%) were categorized as mild (Grade 1) ▪ No SAEs were observed ▪ TEAEs were transient and resolved without medical intervention ▪ Primary cardiovascular TEAE associated with mil
Slide 17: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You 17